Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain
NCT ID: NCT06524531
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
100 participants
INTERVENTIONAL
2024-07-10
2025-12-30
Brief Summary
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Detailed Description
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This study will investigate the effects of pulsed RF neuromodulation on the L2 and L3 segments bilaterally, with each side receiving treatment for 6 minutes. In addition, leukocyte-rich PRP will be injected into the multifidus muscle, and patients will undergo a physiotherapy regimen. The primary outcomes will be compared with those of a control group receiving only physical therapy.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Experimental Group
Pulsed RF Neuromodulation: Administered to the L2 and L3 segments bilaterally for 6 minutes each.
Leukocyte-Rich PRP Injection: Injected into the multifidus muscle. Physiotherapy: Standard physiotherapy regimen.
Pulsed RF Neuromodulation
RF neuromodulation will be applied to the L2 and L3 segments bilaterally. Each segment will receive treatment for 6 minutes, either sequentially or simultaneously on both sides.
Leukocyte-Rich PRP Injection
Leukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels.
Control Group
Physiotherapy: Standard physiotherapy regimen only
Physiotherapy Alone
Standard physiotherapy regimen tailored to each participant's needs. This may include exercises to improve flexibility, strength, and endurance of the back muscles, as well as education on posture and body mechanics.
Interventions
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Pulsed RF Neuromodulation
RF neuromodulation will be applied to the L2 and L3 segments bilaterally. Each segment will receive treatment for 6 minutes, either sequentially or simultaneously on both sides.
Leukocyte-Rich PRP Injection
Leukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels.
Physiotherapy Alone
Standard physiotherapy regimen tailored to each participant's needs. This may include exercises to improve flexibility, strength, and endurance of the back muscles, as well as education on posture and body mechanics.
Eligibility Criteria
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Inclusion Criteria
* Pain persisting for more than 6 months despite conventional treatments.
* Ability to provide informed consent.
Exclusion Criteria
* Current use of systemic steroids or immunosuppressive medications.
* Known bleeding disorders or anticoagulant therapy.
* Pregnancy or lactation.
* Severe psychiatric or cognitive disorders.
* Any Congenital or Non-congenital disorders
30 Years
70 Years
ALL
No
Sponsors
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Iffat Anwar Medical Complex
OTHER
Responsible Party
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Locations
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Iffat Anwar Medical Complex
Lahore, Punjab Province, Pakistan
Countries
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Facility Contacts
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Shahzad Anwar, DOM, MBBS
Role: backup
Other Identifiers
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IAMC003
Identifier Type: -
Identifier Source: org_study_id
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